Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Tandem Diabetes Care, Inc., San Diego, CA, announced FDA approval of its t:slim G4 Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring integration, for use by people 12 years of age or older who use insulin.
ITTIA, Bellevue, WA, a global supplier of embedded database software, announces a release of the popular embedded database ITTIA DB SQL with support for the Freescale Kinetis family of microcontrollers for streamlined development of secure, connected Internet of Things applications. A free copy of ITTIA DB SQL is available for evaluation at: http://www.ittia.com/products/embedded/evaluation .
NovaBone Products, Jacksonville, FL, a leading biologics medical device company, has received FDA approval for its NovaBone MacroFORM MIS Delivery Systemdesigned for bone grafting material use in minimally invasive orthopedic procedures.
Bovie Medical Corporation, Clearwater, FL, a maker of medical devices and supplies, has received FDA 510(k) approval for six new hand piece configurations that expand its J-Plasma® surgical product pistol grip portfolio. In addition, the Bovie® Ultimate™ Operating Room Generator has been named an “Innovation of the Year” by The Society of Laparoendoscopic Surgeons.
Surefire Medical, Inc., Westminster, CO, developer of a new class of direct-to-tumor treatment delivery devices employed in minimally invasive embolization procedures, announced that the company has received FDA 510(k) clearance for its Surefire Precision infusion technology.
ZEISS Medical Technology, Dublin, CA, announced that its AngioPlex OCT Angiography is the first such technology to receive 510(k) clearance from the FDA.
Bestronics, San Jose, CA, which provides a wide range of manufacturing, engineering, testing and material/program management services, announced that it has achieved ISO 13485 certification for its San Jose, CA facility.
Teleflex Incorporated, Wayne, PA, a leading global provider of medical technologies for critical care and surgery, has received FDA 510(k) clearance to market its ARROW® Triple Lumen Pressure Injectable Acute Hemodialysis Catheter.
Salutaris Medical Devices Ltd., London, UK, announced that its SMD Sr90-1 Radionuclide Brachytherapy Source received FDA 510(k) clearance for brachytherapy of tumors and benign growths.
K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing complex spine technologies, techniques, and procedures, has received FDA 510(k) clearance to market its PYRENEES® Mono Cervical Plate System. K2M also received a CE Mark for the system.
Eko Devices, Berkeley, CA, a digital medical device startup, has received FDA clearance to launch its Eko Core, a next generation digital stethoscope.
Clariant, Muttenz, Switzerland, a world leader in specialty chemicals, announced that its Clariant Healthcare Packaging manufacturing facility in Belen, NM, recently obtained ISO 15378:2011 certification for products manufactured for healthcare applications. The New Mexico plant is the second Clariant site to meet the ISO 15378:2011 standards; its manufacturing facility in Romorantin, France, was the first to be certified.
Nextremity Solutions, Red Bank, NJ, which offers novel solutions and approaches to forefoot surgical intervention, has received FDA 510(k) approval to market its upcoming Arcus Staple System.
Royal Philips, Andover, MA, a diversified healthcare technology company, has received FDA 510(k) clearance to market its Spectral Diagnostic Suite, a set of advanced visualization and analysis tools designed to deliver enhanced spectral viewing and advanced clinical applications capabilities.
QT Vascular, Singapore, has received CE Mark approval in the European Union for its Chocolate Touch drug-coated balloon to treat vascular disease.
NewAge Industries, Southampton, PA, a manufacturer of plastic and rubber tubing, announced the promotions of Robert Volk and Michael Allard to newly-created positions. Volk is now the company’s Executive Director of Operations, and Allard’s new position is Executive Director of Sales and Marketing.
Lantheus Holdings, Inc., North Billerica, MA, parent company of Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents and products, has appointed Mary Anne Heino as the new President and Chief Executive Officer and a Director of the company.
Globus Medical, Inc., Audubon, PA, a leading musculoskeletal implant manufacturer, announced that President and Chief Operating Officer, Dave Demski, will assume the position of Group President, Emerging Technologies. Anthony Williams, Senior Vice President of Business Development and General Counsel, will assume the role of President of Globus Medical. Brett Murphy, currently Executive Vice President of US Sales, has been promoted to Group President, Commercial Operations. And, James R. Tobin has been appointed to its Board of Directors.
TransEnterix, Inc., Research Triangle Park, NC, which is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, announced that Paul Ziegler has been named Vice President of Sales.
SI-BONE, Inc., San Jose, CA, a medical device company that pioneered the use of a minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac joint, announced that Karen Licitra and Keith Valentine have been appointed to its Board of Directors.
Gordon Steere, who led Medtronic Tempe from 1997 to 2008, has been selected as the recipient of the 2015 AZBio Pioneer Award for Lifetime Achievement by the Arizona BioIndustry Association.
John A. Rogers, a materials scientist and pioneer in the field of bio-integrated electronic devices, will join Northwestern University, Evanston, IL, as the Louis Simpson and Kimberly Querrey Professor of Materials Science and Engineering, Biomedical Engineering and Medicine, the University announced. He had been the Swanlund Chair at the University of Illinois Urbana-Champaign.
St. Jude Medical, Inc., St. Paul,MN, announced a leadership transition plan whereby Michael T. Rousseau will become President and Chief Executive Officer and a member of the St. Jude Medical Board of Directors, effective January 1, 2016. Daniel J. Starks, who has been Chairman, President, and CEO, will retire and has been elected Executive Chairman of the company’s Medical Board of Directors.
Vention Medical, South Plainfield, NJ, which specializes in the design, development, manufacturing, and assembly of complex medical devices and components, has opened a facility in Israel near Tel Aviv to support innovation in the region’s rapidly growing medical device market. Vention Medical Israel will offer design and development services, catheter components and technologies, and manufacturing services to support rapid product launch and scalable production.
Whitford Corporation, Elverson, PA, manufacturer of the world’s largest, most complete line of fluoropolymer coatings for industrial and consumer industries, has formed a new Medical Coatings Group dedicated to the supply of fluoropolymer coatings for use on medical devices. Construction of the new facility has been completed at the company headquarters, validation work is commencing, and the facility is slated to be fully operational by the end of the 3rd quarter or beginning of the 4th quarter 2015.
Bayer, Leverkusen, Germany, a leading innovator and technology company, opened a plant in San Jose, Costa Rica, to produce a non-reversible permanent contraceptive device. The plant has ISO 13485 certification, which will allow Bayer to market this product in Europe and Canada, as well as FDA approval for sale in the US. This is Bayer’s first medical device site to open in Latin America, although the company has its Central American and Caribbean headquarters in Costa Rica.
GN ReSound, Ballerup, Denmark, a hearing diagnostics equipment maker, is opening a new manufacturing and distribution facility in Johor, Malaysia, which will serve as the central distribution hub for the region.
Medical Excellence Japan, organized to promotethe globalization of Japan’s medical services as public and private partnership, and Toshiba Medical Systems Corporation, Tokyo, Japan, a leading worldwide provider of medical diagnostic imaging systems, have established the Russia-Japan Cardiac Imaging Training Centerin cooperation with I.M. Sechenov First Moscow State Medical University, Moscow, with the goal of improving cardiac diagnostic imaging and treatment in Russia.
Orchid Orthopedic Solutions, Holt, MI, a worldwide leader in design and manufacturing for the orthopedic and medical device markets, has acquired Alhenia AG, Dättwil, Switzerland, a leading provider of coated implants to orthopedic device manufacturers.
Hill-Rom Holdings, Inc., Chicago, IL, a leading global medical technology company, has acquired Welch Allyn, Skaneateles Falls, NY, a manufacturer of medical diagnostic devices, patient monitoring systems, and precision lamps. Alton Shader will be appointed President of Welch Allyn Holdings, Inc. and its consolidated companies following the acquisition.
Danaher Corporation, Washington, DC, a global science and technology innovator, has entered into a definitive merger agreement to acquire Pall Corporation, Port Washington, NY, a leading global provider of filtration, separation and purification solutions that remove contaminants or separate substances from a variety of solids, liquids and gases.
PCH Access, which designs custom manufacturing solutions, has partnered with Johnson & Johnson Innovation LLC, Menlo Park, CA, which supports early-stage innovations for healthcare, to establish Hardware for Health, a medtech hardware accelerator based in the San Francisco area. The program will provide funding and physical space, as well as marketing, distribution and regulatory assistance for medtech products. Interested companies can learn more about the program and apply at hardwareforhealth.com.
Davis-Standard, LLC, Pawcatuck, CT, a global leader in the design, development, and distribution of extrusion and converting technology, announced the acquisition of Gloucester Engineering, Gloucester, MA, a blown film leader and innovator in film applications.
Edwards Lifesciences, Irvine, CA, which specializes in artificial heart valves and hemodynamic monitoring, has acquired CardiAQ Valve Technologies, also Irvine, the developer of a transcatheter mitral valve replacement system.
Keysight Technologies, Inc., Santa Rosa, CA, a global electronic measurement technology leader, has purchased Electroservices Enterprises Ltd., Telford, UK, which provides a broad range of electrical, mechanical, and physical calibration, repair and asset management services.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, has announced that it has acquired Medina Medical, Menlo Park, CA, which focuses on developing treatments for vascular abnormalities of the brain, including cerebral aneurysms.
HeartWare International, Inc., Framingham, MA, a leading innovator of miniaturized circulatory support technologies, has entered into a definitive agreement to acquire Valtech Cardio, Ltd., Or Yehuda, Israel, which specializes in the development of innovative surgical and transcatheter valve repair and replacement devices to treat heart valve diseases.
Abbott, Abbott Park, IL, a global healthcare company, announced that it has completed its acquisition of Tendyne Holdings, Inc., Roseville, MN, a medical device company focused on developing minimally invasive mitral valve replacement therapies.
Titan Spine LLC, Mequon, WI, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, has entered into a distribution agreement with MBA Incorporado, Asturias, Spain, a leading medical device marketing and distribution organization, as a partner to provide Titan’s titanium implants to spine surgeons in six countries across Europe.
NSF International, Ann Arbor, MI, a leading provider of regulatory compliance, quality systems, analytical testing, education, and consulting services for the medical device sector, has acquired Avarent LLC, Libertyville, IL, a consulting firm with expertise in medical device products/processes development, design control, validation, quality assurance, and regulatory compliance. Avarent will be renamed NSF Avarent.
Integra LifeSciences Holding Company, Plainsboro, NJ, which offers a broad portfolio of implants, devices, instruments, and systems, has acquired the US rights to ankle replacement products and silastic toe replacement products from Tornier, Amsterdam, The Netherlands,a global medical device company focused on providing solutions to treat musculoskeletal injuries and joint disorders. The transaction is subject to US Federal Trade Commission approval and the closure of the pending merger between Tornier and Wright Medical Group.
Allergan, Dublin, Ireland, a global pharmaceutical company, is acquiring AqueSys Inc., Aliso Viejo, CA, an ophthalmic devicemaker focused on implantable devices to treat glaucoma.
Valeant Pharmaceuticals International, Inc., Montreal, Canada, a diverse and decentralized pharmaceutical company, has agreed to acquire Synergetics USA, Inc., O'Fallon, MO, a supplier of precision surgical devices.
Pfizer Inc., New York, NY, one of the world’s largest innovative biopharmaceutical companies, has completed its acquisition of Hospira, Inc., Lake Forest, IL, the world’s leading provider of injectable drugs and infusion technologies.
The Institute for Applied Neurosciences, a non-profit technology accelerator embedded within the Medical University of South Carolina in Charleston, has licensed a novel, patented minimally invasive spine surgery product to Amendia, Inc., Marietta, GA, a leading provider of innovative medical devices used during spinal surgical procedure.
Bayer MaterialScience, Leverkusen, Germany, one of the world’s leading polymer materials suppliers, is now operating under a new name, Covestro. The company, now legally and economically independent, will remain a 100 percent subsidiary of Bayer AG.
RTP Company, Winona, MN, a leading global compounder of custom engineered thermoplastics that solve medical application challenges around the world, has developed an innovative friction test to accurately predict friction behavior in single-use devices. For more information on material selection data, visit www.rtpcompany.com .
Newcomb Spring Corp., Decatur, GA, has introduced Android and iPad compatibility for its innovative Springulator® spring calculator application. The app allows engineers, designers, and purchasing agents to check the design and functionality of compression springs, extension springs, and torsion springs. New versions of the free app are available through the AppStore and Google Play. It is also available as a web-based version at www.springulator.com .
Native Design Studio, London, UK, is the first British design agency to win IDEA Gold and Best in Show at the Industrial Designers Society of America International Conference. Its creation of Coloplast’s Design DNA won a Gold International Design Excellence Award (IDEA) for Design Strategy, and was selected as overall Best in Show.
Thomson Industries, Inc., Wood Dale, IL, a leading manufacturer of mechanical motion control solutions, has released a new educational video to help design engineers correctly service the Thomson Motorized Lead Screw in the field. The units combine a hybrid stepper motor and lead screw in one compact design.
Cambridge Endoscopic Devices Inc., Framingham, MA, which specialized in developing hand-held endoscopic instruments, has filed for chapter 11 bankruptcy protection.
Nordson ASYMTEK, Carlsbad, CA, a Nordson company, a global leader in dispensing, jetting, and coating equipment and technologies, has been selected as a finalist for the San Diego Business Journal 2015 Manufacturing Award.